Current methods for the diagnosis and management of neoplastic disease rely heavily on imaging techniques, such as X-ray, CT scanning and MRI, tissue biopsy and histopathological findings. Much effort has been put forth to identify other less costly and less invasive means for the diagnosis and monitoring of cancers. In certain cases specific molecular tumor markers have been identified that show promise as potential diagnostic and prognostic indicators, but unfortunately, most of these markers lack the requisite specificity and sensitivity. The long-term objective of this research program is to develop immunodiagnostic assays for the detection of the tumor marker, human aspartyl (asparaginyl) beta-hydroxylase (HAAH). Recent work has demonstrated the over-expression of HAAH in a wide variety of malignant tumors, including pancreatic carcinoma, glioblastoma multiforme, hepatocellular carcinoma, and cholangiocarcinoma. Additionally, unlike other potential tumor markers, over-expression of HAAH displays high specificity for malignant cells. The dismal prognosis associated with cancer of the pancreas is because very few of these cancers are found prior to their spread to other organs. To date, no molecular markers for pancreatic cancer have been identified, validated and accepted for clinical use for early diagnosis. The Specific Aims of this proposal are to establish HAAH as a soluble marker for pancreatic cancer, to develop highly sensitive and specific immunoassays for the detection of HAAH in bodily fluids, and to correlate the levels of HAAH in the serum and/or pancreatic juice of individuals diagnosed with pancreatic carcinoma to disease diagnosis and patient outcome.